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FDA give full approval to Pfizer COVID vaccine; Local officials urge Tucsonans to get shots

The Food and Drug Administration granted full approval to the Pfizer-BioNTech coronavirus vaccine Monday—an announcement that removes at least one barrier for those hesitant to get the shot as dozens of employers have moved forward with vaccine mandates.

This includes the city of Tucson, which instituted a COVID-19 vaccine mandate for employees that begins this week, kindling a political fight between the Tucson officials and state Republicans, including Gov. Doug Ducey, and the state attorney general.

The FDA beat its goal to approve the Pfizer vaccine by Labor Day, hitting a milestone in the fight against COVID-19 during an increasing surge in new cases and hospitalizations driven by the Delta variant.

Pfizer's vaccine was cleared for those 16 and older, and will be marketed under the brand name Comirnaty, the FDA said. The vaccine continues to be available under the emergency use authorization for children 12-15, and third "booster" doses will also remain available under the emergency use approval.

Children under 12 have not been cleared to receive the vaccine, and the FDA has yet to clear the Moderna and Johnson and Johnson vaccines.

"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Dr. Janet Woodcock, acting FDA commissioner. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," Woodcock said. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S."

The FDA said that it reviewed data from the clinical trial, which analyzed the effectiveness of the Pfizer vaccine among 42,000 people—including 20,000 who received the vaccine and 20,000 who received a placebo. Based on results from the clinical trial, the vaccine was 91 percent effective in preventing COVID-19, the FDA said.

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The clinical trial evaluated 42,000 people for safety issues, and more than half of the clinical trial participants were followed for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months, the agency said.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities," said Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.

"We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S," he said.

The FDA's authorization follows a weekend of spiking case loads in Arizona, as health officials confirmed another 3,307 cases in the state on Sunday. Over the last seven days, there have been more than 20,600 new reported coronavirus infections with 136 deaths.

Pima County, with 229 new cases, is seeing daily new infections not experienced since February as the latest pandemic wave continues. The county Health Department issued a new public health advisory Tuesday, saying that local hospitals are "stretched thin" and seeking federal assistance to deal with the "unprecedented surge" in COVID cases and other admissions. On Friday, there were just 7 intensive care beds available in all of Pima County's hospitals, in part due to the number of COVID patients being treated.

Dr. Theresa Cullen, the director of the Pima County Health Department, said that she was "optimistic" that the FDA's full approval will "alleviate any concerns for people who were hesitant about the vaccine, even though the emergency use authorization met rigorous scientific standards."

"The science is clear," she said.

"With more than 200 million Americans having received at least one dose of the COVID-19 vaccines, the public can be very confident in their safety and effectiveness," Cullen said. "The vaccines are our best tool against the pandemic. More than 72 percent of Pima County residents 12 and older have received at least one dose of a COVID-19 vaccine, and, for those who have been waiting, the best time is now."

Arizona Department of Health officials called the FDA's approval a "critical step toward ending the pandemic."

"If the term 'emergency use authorization' has kept you from getting vaccinated against COVID-19, it's time to  join millions of Arizonans who protected themselves, their families, and their communities," wrote state health officials.

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"Over the decades, vaccines have brought to heel polio, smallpox, tetanus, whooping cough, measles, and many other concerning diseases," said Dr. Cara Christ, the outgoing director of the Arizona Department of Health Services. "The approved COVID-19 vaccines, which benefit from 20 years research into coronaviruses, offer the surest protection against a virus that continues hospitalizing and killing those who aren’t vaccinated," she said.

From July through the first half of August, more than 86 percent of new COVID-19 cases were among those who weren't fully vaccinated. While vaccinated people can still get COVID-19, their cases are milder, and often they have few, if any, symptoms.

However, nearly 91 percent of those hospitalized in July, and 86 percent of those who died from COVID-19 were not fully vaccinated, ADHS said.

Arizona Gov. Doug Ducey called the FDA's approval "welcome news."

"My sincere hope is that today’s welcome news from the FDA helps remove a barrier for many Arizonans who are hesitant to get the vaccine," said Ducey. "There’s never been a better reason to join me and the nearly 4 million people in our state who have received these safe, free, and highly effective vaccines."

Ducey's statement comes after the governor went toe-to-toe with the city of Tucson after Mayor Regina Romero and the City Council passed a resolution requiring city government employees to get vaccinated by Tuesday, August 24, or face suspension without pay.

In a 6-1 vote, the Council moved to require all city employees to present proof they are vaccinated, or begin the process of getting vaccinated by getting their first shot by Tuesday.

About 79 percent of city employees said they are already vaccinated against COVID-19, according to an internal survey, said City Manager Mike Ortega in a memo, leaving about 1,000 employees unprotected by the vaccine. The study showed that 79 percent of the 3,300 respondents said they were vaccinated, but about 26 percent of the workforce didn't respond.

Employees could face suspensions of up to five days without pay if they aren't vaccinated.

In response, Ducey issued an executive order, proclaiming that any county, city, town or "political subdivision" official who implements a vaccine mandate is in violation of state law, and said that such  "actions are punishable by a class 3 misdemeanor." 

Ducey argued that his order is "consistent" with legislation he signed into law in June that blocked vaccine and mask mandates.

"Gov. Ducey is paving the way for COVID-19 to spread uncontrollably throughout our state, and attempting to impede those of us who believe in science-based solutions at the local level," said Romero. “After consulting with our city attorney, it is clear that this executive order is legally meaningless. The action that mayor and Council took last Friday will remain in full effect."

"Gov. Ducey must stop prioritizing his political aspirations over the health and well-being of Arizonans," she wrote. "We have seen the deadly repercussions of similar approaches by the governors of Texas and Florida, yet Gov. Ducey is consciously deciding to head down the same path knowing full well what the consequences are. Gov. Ducey is playing a deadly game of one-upmanship that will lead to preventable hospitalizations and deaths."

Mike Rankin, the city attorney, wrote that the governor's edict has "no effect on the actions" taken by the City Council.

Pima County's Republican Party meanwhile decided to push for the arrest of elected officials if they require mask or vaccines, a sign of the increasing politicization of such mandates in the face of the rising COVID-19 cases in hospitals.

Arizona Attorney General Mark Brnovich issued a legal opinion, writing that "while public health measures may be pursued during emergencies, they cannot trample constitutionally guaranteed liberties."

"Arizonans should be free, without coercion, to make medical decisions regarding vaccination that they feel are best for themselves and their families," Brnovich wrote. He said that while schools, public universities, community colleges, state and local governments are prohibited from requiring employees to obtain COVID-19 vaccines, private business can mandate vaccinations. However, he wrote that private employers must "provide reasonable accommodations for employees who cannot obtain the COVID-19 vaccine due to a disability or a sincerely held religious belief."

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Brnovich's argument hinged entirely on the fact that the Pfizer vaccine, along with others, was based on the emergency use authorization. Further, Brnovich did not make clear if this situation would change once the FDA cleared the vaccines for regular use.

Along with the city of Tucson, Banner Health and Tucson Medical Center both instituted mandates for vaccines, and the Pentagon announced Monday that military personnel will also have to be vaccinated.

U.S. Rep. Raúl Grijalva joined the chorus of praise for the FDA's approval, writing in a statement that it was a "welcome development."

"I hope that it will mark yet another turning point in the fight against COVID-19," he said. "The scientific community came together, and with massive federal investments, developed a safe and highly effective vaccine. Despite the medical community's agreement that the vaccines are safe, I understand that some continue to be hesitant because they were approved on an Emergency Use basis. Today everyone can have even more confidence in this vaccine - the benefits are clear."

"This has become a pandemic of the unvaccinated as our hospitals are flooded with individuals that have chosen not to be vaccinated, or those that are not yet eligible, including young children," Grijalva said.  "Unvaccinated people are still more likely to contract and spread COVID, and much more likely to become hospitalized. I hope this announcement will put many of the falsehoods and anti-vaccination misinformation campaigns to rest."

Grijalva also pushed for social media companies to do more to "stop the massive spread of misinformation on their platforms."

"These anti-vaccination campaigns are profiting off people’s deaths, and we cannot allow this to continue," he said. 

ADHS urged people to get vaccinated, reminding young people to "think again" if they believe that simply being a young adult guarantees their safety. 

"Nearly half of all cases are occurring among those ages 20 to 44, the group with the lowest vaccination rates among adults," said ADHS. "Nearly one out of three people hospitalized for COVID-19 since June have been ages 20 to 44.

"That’s 1,583 people from what should be the fittest age group being hospitalized and facing severe illness and even death," ADHS said, adding that 54 people, or about 12 percent of COVID-19 deaths in Arizona since June, were among those 20 to 44.

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Paul Ingram/TucsonSentinel.com

Vaccines at a clinic in January at Tucson Medical Center.

Stop the spread

The Pima County Health Department asks the public to help stop community spread of COVID-19 by taking the following steps:

  • Get vaccinated against COVID-19 and flu
  • Wear a mask when indoors, at schools and in public places
  • Wash your hands frequently
  • Limit gathering in public spaces
  • Limit travel that is not essential
  • Get tested if you have COVID-like symptoms
  • Isolate for 10 days from others if you test positive
  • Quarantine if you are exposed to someone who tests positive

The Last Best Shot

Editor's note: TucsonSentinel.com is one of dozens of news organizations around the country that are noted for reporting on the COVID-19 pandemic, and participating in "The Last Best Shot," an effort led by The Boston Globe to combat COVID-19 vaccination disinformation.

We have a clear choice. We can mark the start of a future in which COVID is relegated to little more than a nuisance, or we can watch the disease spiral further out of our grasp. Nearly 18 months after the pandemic shuttered much of the world, we are still in a state of uncertainty, one that threatens to steal yet another season and kill people who don't need to die.

The Last Best Shot reporting being published by the Sentinel and more than 50 outlets around the nation is meant to reinforce a simple fact: The only way out is vaccination. For every eligible person. Now.

See all of the #LastBestShot stories on the Sentinel here, and all of our coronavirus reporting here.


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